Clinical Study Planning Manager - Los Angeles, United States - Amgen
Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career.
How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do.
It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.Clinical Study Planning Manager
Live:
What you will do
Let's do this. Let's change the world.
In this vital role you will be responsible for driving cross functional planning and effective execution of studies through the development of realistic study timelines and objective communication of project status to improve global therapeutic value.
Key Responsibilities- Own the development of and supervise the implementation of highquality, realistic, crossfunctional, global clinical trial timelines, from design through final study reporting, in Amgen's planning systems within specified deadlines
- Lead, implement and communicate changes per the Change Impact Assessment Review & Approval (CIARA) process or other mechanisms as appropriate
- Ensure alignment of funding/investment of clinical studies within assigned programs to support operational planning by functions (i.e., via monthly RAP, annual LRP, quarterly LE, etc.)
- Maintain accuracy of clinical study timeline information in Amgen data control systems (e.g., Planisware PPM), through conducting integrity checks and data issue resolution on a routine basis for assigned study timelines
- Partner with Resource Forecasting Group staff to support optimized planning of resources and budget.
- Communicate information on clinical trial status, changes, and issues to team members, and confirm acceptance of clinical study timelines with functional representatives ensuring alignment with key operational goals and timelines
- Increase the efficiency of trial operations through the sharing of crossprogram knowledge and identification of standard leading to standardization across the organization
- Build scenario options in support of decisionmaking for operational or strategic direction
- Participate in (or lead) process improvement initiatives as assigned
Win:
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
What we seek in you as an experienced professional, are these qualifications and skills:
Basic Qualifications:
- Doctorate degree OR
- Master's degree and 2 years of work experience in life science OR
- Bachelor's degree and 4 years of work experience in life science OR
- Associate's degree and 8 years of work experience in life science OR
- High school diploma / GED and 10 years of work experience in life science
Preferred Qualifications:
- Broad work experience in life sciences or medically related filed, including general biopharmaceutical clinical product development (clinical research or clinical operations experience acquired at a biotech, [pharmaceutical or CRO company)
- Drug development knowledge with understanding of other functions, including Pre-Clinical, Clinical, Development Operations, and Regulatory
- Project management tools and processes (e.g., MS Project, Planisware, PowerPoint)
Thrive:
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
- Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
- A discretionary annual bonus program, or for field sales representatives, a salesbased incentive plan
- Stockbased longterm incentives
- Awardwinning timeoff plans and biannual companywide shutdowns
- Flexible work models, including remote work arrangements, where possible
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
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